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Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

Information source: Ito Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Disease; Parathyroid Disease

Intervention: PIPC piperacillin sodium (Drug); CEZ, cefazolin sodium (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ito Hospital

Official(s) and/or principal investigator(s):
Takashi Uruno, MD, Principal Investigator, Affiliation: Ito Hospital

Summary

The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.

Clinical Details

Official title: Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Surgical site infections after thyroid and parathyroid surgery

Secondary outcome: Side effect of the drug for Antimicrobial prophylaxis

Detailed description: Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital and randomized in three groups; Group A (n=541): operation with AMP (PIPC, piperacillin sodium), Group B (n=541): operation with AMP (CEZ, cefazolin sodium), and Group C (n=1082): operation without AMP. Exclusion criteria

- Patients who did not agree to attend the randomized control study.

- Patients who received the operation including mediastinum with sternotomy.

- Patients who received the operation including additional resection of trachea,

esophagus and larynx.

- Patients who received the re-operation for post-operative bleedings.

- Patients who had known allergy to cephem or penicillin.

Eligibility

Minimum age: 10 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend

the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital. Exclusion Criteria:

- Patients who did not agree to attend the randomized control study.

- Patients who received the operation including mediastinum with sternotomy.

- Patients who received the operation including additional resection of trachea,

esophagus and larynx.

- Patients who received the re-operation for post-operative bleedings.

- Patients who had known allergy to cephem or penicillin.

Locations and Contacts

Ito Hospital, Tokyo 150-8308, Japan
Additional Information

Starting date: November 2010
Last updated: March 5, 2013

Page last updated: August 23, 2015

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